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Optimising control of diabetes before surgery


- candidate number29583
- NTR NumberNTR7497
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-sep-2018
- Secondary IDsABR 67034
- Public TitleOptimising control of diabetes before surgery
- Scientific TitleIndividualised Preoperative Optimisation of Glycaemic Control in Patients with Diabetes Mellitus
- ACRONYMThe IPOD trial
- hypothesisPoor glycaemic control, indicated by an elevated HbA1c, is correlated to poor postoperative outcome in patients with diabetes mellitus undergoing surgery. However, improving glycaemic control before surgery has not been extensively studied so far. We hypothesise that improving glycaemic control, using an individualised approach guided by a specialised diabetes care nurse, will improve postoperative outcomes, measured as number of days spent at home in the thirty days after surgery.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus, Perioperative care, Pre-operative, Glucose, Glucose metabolism
- Inclusion criteria- Diabetes mellitus type 2 (diagnosis at least 3 months prior to pre-operative screening)
- Age 18 - 85 years
- Elective non-cardiac surgery
- Scheduled for surgery at least 7 days from date of screening
- Informed consent
- Exclusion criteria- Bariatric surgery
- Palliative surgery
- Outpatient or day case surgery
- (Potentially) pregnant or breast-feeding
- Unable to communicate in Dutch or English, psychiatric disorder, known therapy incompliance or deemed unfit by the researchers for another reason
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2018
- planned closingdate
- Target number of participants200
- InterventionsOn the day of preoperative consultation, HbA1c will be measured. Patients with an HbA1c <53 mmol/mol will proceed to surgery according to standard care. Patients with an HbA1c >=53 mmol/mol will be randomised to an intervention group or control group.
Patients in the intervention group will be contacted by a diabetes care nurse for optimisation of their glycaemic control before surgery. Patients in the control group will proceed to surgery according to standard care.
- Primary outcomeThe primary endpoint of the study will be the number of days at home up to 30 days after surgery (DAH30), which is a single, pragmatic, patient-centred outcome.
- Secondary outcomeSecondary outcomes are preoperative and postoperative blood glucose concentrations, incidence of hyperglycaemia and hypoglycaemia (glucose >10 mmol/l or <4 mmol/l, respectively) and change from baseline HbA1c, fructosamine, and 1,5- anhydroglucitol.
- Timepoints- Preoperative consultation: blood glucose, HbA1c, fructosamine, 1,5 AG
- Day of surgery: blood glucose, HbA1c, fructosamine, 1,5 AG.
- 30 days after surgery: number of days at home up to 30 days after surgery
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES A.H. Hulst
- CONTACT for SCIENTIFIC QUERIESDrs. R. van Wilpe
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Amsterdam
- Publications
- Brief summaryPoor glycaemic control, indicated by an elevated HbA1c, is correlated to poor postoperative outcome in patients with diabetes mellitus undergoing surgery. However, improving glycaemic control before surgery has not been extensively studied so far. We hypothesise that improving glycaemic control, using an individualised approach guided by a specialised diabetes care nurse, will improve postoperative outcomes, measured as number of days spent at home in the thirty days after surgery. In general, this study will provide more insight in the importance of glycaemic control before surgery and its ability to improve postoperative outcomes.
- Main changes (audit trail)
- RECORD25-sep-2018 - 6-okt-2018


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